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Acupuncture and PC6 stimulation for the prevention of postoperative nausea and vomiting in patients undergoing elective laparoscopic resection of colorectal cancer: a study protocol for a three-arm randomised pilot trial

Acupuncture and PC6 stimulation for the prevention of postoperative nausea and vomiting in patients undergoing elective laparoscopic resection of colorectal cancer: a study protocol for a three-arm randomised pilot trial

3Department of Surgery, Pusan National University Yangsan Hospital, Yangsan, South Korea

4Department of Anesthesia and Pain Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea

Correspondence to
Professor Hee Young Kim; yuvi1981{at}naver.com

Abstract

Introduction This study aims to assess the feasibility of acupuncture and a Pericardium 6 (PC6) wristband as an add-on intervention of antiemetic medication for the prevention of postoperative nausea and vomiting (PONV) in patients undergoing elective laparoscopic colorectal cancer resection.

Methods and analysis A total of 60 participants who are scheduled to undergo elective laparoscopic resection of colorectal cancer will be recruited. An enhanced recovery after surgery protocol using standardised antiemetic medication will be provided for all participants. Participants will be equally randomised into acupuncture plus PC6 wristband (Acupuncture), PC6 wristband alone (Wristband), or no acupuncture or wristband (Control) groups using computer-generated random numbers concealed in opaque, sealed, sequentially numbered envelopes. For the acupuncture combined with PC6 wristband group, the embedded auricular acupuncture technique for preoperative anxiolysis and up to three sessions of acupuncture treatments with manual and electrical stimulation within 48 hours after surgery will be provided by qualified Korean medicine doctors. The PC6 wristband will be applied in the Acupuncture and Wristband groups, beginning 1 hour before surgery and lasting 48 hours postoperatively. The primary outcome will be the number of participants who experience moderate or severe nausea, defined as nausea at least 4 out of 10 on a severity numeric rating scale or vomiting at 24 hours after surgery. Secondary outcomes, including symptom severity, participant global assessments and satisfaction, quality of life, physiological recovery, use of medication and length of hospital stay, will be assessed. Adverse events and postoperative complications will be measured for 1 month after surgery.

Ethics and dissemination All participants will provide written informed consent. The study has been approved by the institutional review board (IRB). This pilot trial will inform a full-scale randomised trial of acupuncture combined with PC6 stimulation for the prevention of PONV in patients undergoing elective laparoscopic colorectal cancer surgery.

Trial registration number NCT02509143.

acupuncture

postoperative nausea and vomiting

colorectal cancer

omplementary and alternative medicine

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

Contributors KHK and HYK conceived the study. KHK, DHK, GMS, KyHK, GYY and HYK initiated the study design and drafted the protocol. All authors contributed to the refinement of the study protocol and approved the final manuscript. KHK is the guarantor of this manuscript.

Funding This study is supported by a Biomedical Research Institute Grant (2015-00), Pusan National University Hospital (contact information: mri@pnuh.co.kr; 82-51-240-7526).

Disclaimer The funding body has no role in the study design and will not play any role during its execution, analyses, interpretation of the data, or decision to submit the report for publication.

Data sharing statement Requested data for public purpose or research transparency will be provided (please contact the first or corresponding author).

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Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/